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Octocog alfa

Summary

Hazard - P - B - T - Risk Exempt

Assessment report

Assessment report for Kovaltry (octocog alfa) 17 December 2015, EMA/CHMP/40124/2016 rev. 1.

"BAY 81-8973/octocog alfa is a recombinant replacement protein of the naturally occurring coagulation factor VIII. It is catabolized during human metabolism and no active molecule is excreted by the patient. In accordance with the guideline CHMP/SWP/4447/00 (1), BAY 81-8973/octocog alfa as a protein is exempted from an environmental risk assessment since proteins are unlikely to result in a significant risk to the environment."

Fass environmental information

Fass environmental information for Helixate NexGen (octocog alfa) from CSL Behring (downloaded 2019-08-20) and Kogenate Bayer (octocog alfa) from Bayer (downloaded 2019-08-20).

Risk

The use of amino acids, proteins and peptides is not expected to have any environmental impact.

Detailed information

According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00) vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.

References

  1. European Medicines Agency. European public assessment reports (EPAR).
  2. Fass för vårdpersonal.
  3. European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.

Author: Health and Medical Care Administration, Region Stockholm